{"id":9857,"date":"2026-02-24T15:11:45","date_gmt":"2026-02-24T07:11:45","guid":{"rendered":"https:\/\/www.packqc.com\/standard\/astm-f2338-2\/"},"modified":"2026-04-16T09:53:23","modified_gmt":"2026-04-16T01:53:23","slug":"astm-f2338","status":"publish","type":"standard","link":"https:\/\/www.packqc.com\/cs\/standard\/astm-f2338\/","title":{"rendered":"ASTM F2338"},"content":{"rendered":"<p>V\u00fdznam normy ASTM F2338 pro kvalitu obal\u016f<\/p>\n\n\n\n<p>Obal slou\u017e\u00ed jako prvn\u00ed bari\u00e9ra proti kontaminaci. I mikroskopick\u00e9 net\u011bsnosti v t\u011bsn\u011bn\u00ed nebo materi\u00e1lech mohou umo\u017enit vniknut\u00ed kysl\u00edku, vlhkosti nebo mikroorganism\u016f. U farmaceutick\u00fdch v\u00fdrobk\u016f m\u016f\u017ee jedin\u00e1 nezji\u0161t\u011bn\u00e1 net\u011bsnost ohrozit bezpe\u010dnost pacienta. Norma ASTM F2338 \u0159e\u0161\u00ed tento probl\u00e9m t\u00edm, \u017ee nab\u00edz\u00ed <strong data-start=\"1180\" data-end=\"1237\">validovan\u00e1, nedestruktivn\u00ed a opakovateln\u00e1 zku\u0161ebn\u00ed metoda.<\/strong> kter\u00e1 jde nad r\u00e1mec tradi\u010dn\u00edch destruktivn\u00edch metod, jako je vniknut\u00ed barviva nebo emise bublin.<\/p>\n\n\n\n<p>Tato norma je cenn\u00e1 zejm\u00e9na pro <strong data-start=\"1370\" data-end=\"1411\">detekce net\u011bsnosti farmaceutick\u00fdch obal\u016f<\/strong>, kde regula\u010dn\u00ed org\u00e1ny zd\u016fraz\u0148uj\u00ed pot\u0159ebu p\u0159esn\u00fdch, neinvazivn\u00edch metod, kter\u00e9 zachovaj\u00ed testovan\u00e9 vzorky pro dal\u0161\u00ed pou\u017eit\u00ed nebo distribuci.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Jak funguje metoda vakuov\u00e9ho rozpadu<\/h2>\n\n\n\n<p>Metoda ASTM F2338 je zalo\u017eena na p\u0159esn\u00e9m <strong data-start=\"1642\" data-end=\"1690\">monitorov\u00e1n\u00ed tlaku v uzav\u0159en\u00e9 zku\u0161ebn\u00ed komo\u0159e<\/strong>. Zde je zjednodu\u0161en\u011b pops\u00e1n postup:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Obal je um\u00edst\u011bn v pevn\u00e9 zku\u0161ebn\u00ed komo\u0159e.<\/li>\n\n\n\n<li>V komo\u0159e se vytvo\u0159\u00ed vakuum a komora se odd\u011bl\u00ed od zdroje.<\/li>\n\n\n\n<li>Sn\u00edma\u010de tlaku s vysok\u00fdm rozli\u0161en\u00edm m\u011b\u0159\u00ed jak\u00fdkoli n\u00e1r\u016fst tlaku v pr\u016fb\u011bhu \u010dasu.<\/li>\n\n\n\n<li>Zv\u00fd\u0161en\u00ed tlaku znamen\u00e1 \u00fanik plynu z obalu v d\u016fsledku net\u011bsnosti.<\/li>\n<\/ul>\n\n\n\n<p>Na rozd\u00edl od vizu\u00e1ln\u00ed kontroly nebo zkou\u0161ky barvivem je metoda vakuov\u00e9ho rozkladu <strong data-start=\"2085\" data-end=\"2169\">kvantitativn\u00ed, citliv\u00e9 a nevy\u017eaduj\u00edc\u00ed zm\u011bnu nebo zni\u010den\u00ed obalu.<\/strong>. U spr\u00e1vn\u011b kalibrovan\u00fdch syst\u00e9m\u016f dok\u00e1\u017ee odhalit net\u011bsnosti o velikosti pouh\u00fdch n\u011bkolika mikron\u016f.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Aplikace nedestruktivn\u00ed detekce \u00fanik\u016f<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">Detekce \u00faniku farmaceutick\u00fdch obal\u016f<\/h3>\n\n\n\n<p>U steriln\u00edch farmaceutick\u00fdch obal\u016f, jako jsou injek\u010dn\u00ed lahvi\u010dky, injek\u010dn\u00ed st\u0159\u00edka\u010dky nebo blistry, norma ASTM F2338 zaru\u010duje, \u017ee. <strong data-start=\"2473\" data-end=\"2510\">neporu\u0161enost uz\u00e1v\u011bru kontejneru (CCI)<\/strong>. D\u00edky tomu, \u017ee metoda zabra\u0148uje pronik\u00e1n\u00ed \u0161kodliv\u00fdch mikrob\u016f, hraje z\u00e1sadn\u00ed roli p\u0159i dodr\u017eov\u00e1n\u00ed p\u0159edpis\u016f.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Testov\u00e1n\u00ed integrity potravin\u00e1\u0159sk\u00fdch a n\u00e1pojov\u00fdch obal\u016f<\/h3>\n\n\n\n<p>U vakuov\u011b balen\u00fdch potravin, flexibiln\u00edch s\u00e1\u010dk\u016f nebo z\u00e1sobn\u00edk\u016f s v\u00ed\u010dkem je zaji\u0161t\u011bn\u00ed hermetick\u00e9ho uzav\u0159en\u00ed nezbytn\u00e9 pro bezpe\u010dnost v\u00fdrobku a prodlou\u017een\u00ed jeho trvanlivosti. Norma ASTM F2338 nab\u00edz\u00ed \u00fa\u010dinn\u00fd zp\u016fsob testov\u00e1n\u00ed bez pl\u00fdtv\u00e1n\u00ed produktem.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Balen\u00ed zdravotnick\u00fdch prost\u0159edk\u016f<\/h3>\n\n\n\n<p>Zdravotnick\u00e9 z\u00e1sobn\u00edky, s\u00e1\u010dky a bari\u00e9rov\u00e9 obaly mus\u00ed z\u016fstat neporu\u0161en\u00e9 a\u017e do m\u00edsta pou\u017eit\u00ed. Nedestruktivn\u00ed detekce net\u011bsnost\u00ed zaji\u0161\u0165uje, \u017ee tyto obaly spl\u0148uj\u00ed p\u0159\u00edsn\u00e9 normy kvality.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">V\u00fdhody normy ASTM F2338 oproti jin\u00fdm metod\u00e1m<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong data-start=\"3152\" data-end=\"3170\">Nedestruktivn\u00ed<\/strong> - Vzorky z\u016fst\u00e1vaj\u00ed neporu\u0161en\u00e9 a mohou b\u00fdt vr\u00e1ceny do v\u00fdroby.<\/li>\n\n\n\n<li><strong data-start=\"3234\" data-end=\"3254\">Vysoce citliv\u00e9<\/strong> - Detekuje men\u0161\u00ed \u00faniky, ne\u017e jak\u00e9 lze identifikovat vizu\u00e1ln\u00edmi metodami.<\/li>\n\n\n\n<li><strong data-start=\"3317\" data-end=\"3341\">Kvantitativn\u00ed v\u00fdsledky<\/strong> - Poskytuje m\u011b\u0159iteln\u00e9 \u00fadaje nam\u00edsto subjektivn\u00edho vizu\u00e1ln\u00edho potvrzen\u00ed.<\/li>\n\n\n\n<li><strong data-start=\"3417\" data-end=\"3442\">P\u0159ijet\u00ed pr\u00e1vn\u00edch p\u0159edpis\u016f<\/strong> - Je \u0161iroce uzn\u00e1v\u00e1n farmaceutick\u00fdm pr\u016fmyslem a pr\u016fmyslem zdravotnick\u00fdch prost\u0159edk\u016f.<\/li>\n\n\n\n<li><strong data-start=\"3520\" data-end=\"3538\">N\u00e1kladov\u011b efektivn\u00ed<\/strong> - Eliminuje pl\u00fdtv\u00e1n\u00ed materi\u00e1lem p\u0159i destruktivn\u00edm testov\u00e1n\u00ed.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">V\u00fdb\u011br spr\u00e1vn\u00e9ho za\u0159\u00edzen\u00ed pro testov\u00e1n\u00ed podle normy ASTM F2338<\/h2>\n\n\n\n<p>Prov\u00e1d\u011bt <a href=\"https:\/\/www.astm.org\/f2338-09r20.html\" target=\"_blank\" rel=\"noopener nofollow\">ASTM F2338<\/a> jsou zapot\u0159eb\u00ed p\u0159esn\u00e9 p\u0159\u00edstroje. Na str\u00e1nk\u00e1ch <strong data-start=\"3731\" data-end=\"3781\">MLT-01 <a href=\"https:\/\/www.packqc.com\/cs\/products\/mlt-01-vacuum-decay-leak-test-equipment\/\" target=\"_blank\" rel=\"noreferrer noopener\">Micro Leak Tester<\/a> od Cell Instruments<\/strong> je navr\u017een speci\u00e1ln\u011b pro <strong data-start=\"3811\" data-end=\"3835\">testov\u00e1n\u00ed rozpadu ve vakuu<\/strong>. D\u00edky vysoce citliv\u00fdm senzor\u016fm, p\u0159izp\u016fsobiteln\u00fdm velikostem komor a u\u017eivatelsky p\u0159\u00edv\u011btiv\u00e9mu \u0159\u00eddic\u00edmu syst\u00e9mu PLC poskytuje MLT-01 spolehliv\u00e9 v\u00fdsledky pro \u0161irokou \u0161k\u00e1lu typ\u016f balen\u00ed.<\/p>\n\n\n\n<p>Spole\u010dnosti zab\u00fdvaj\u00edc\u00ed se <strong data-start=\"4034\" data-end=\"4111\">detekce net\u011bsnosti farmaceutick\u00fdch obal\u016f nebo testov\u00e1n\u00ed neporu\u0161enosti obal\u016f potravin.<\/strong> bude t\u011b\u017eit ze schopnosti p\u0159\u00edstroje odhalit nepatrn\u00e9 \u00faniky p\u0159i zachov\u00e1n\u00ed produktivity. Integrac\u00ed takov\u00e9ho modern\u00edho za\u0159\u00edzen\u00ed v\u00fdrobci pos\u00edl\u00ed zaji\u0161t\u011bn\u00ed kvality a dodr\u017eov\u00e1n\u00ed mezin\u00e1rodn\u00edch norem.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Kontaktujte n\u00e1s Z\u00edskejte \u0159e\u0161en\u00ed pro testov\u00e1n\u00ed ASTM F2338 <\/h2>\n\n\n\n<p><a href=\"https:\/\/store.astm.org\/f2338-24.html\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ASTM F2338<\/a> poskytuje spolehliv\u00fd a ov\u011b\u0159en\u00fd p\u0159\u00edstup k <strong data-start=\"4897\" data-end=\"4931\">nedestruktivn\u00ed detekce \u00fanik\u016f<\/strong> pro balen\u00ed. Pou\u017eit\u00edm metody vakuov\u00e9ho rozkladu v\u00fdrobci zaji\u0161\u0165uj\u00ed, \u017ee <strong data-start=\"5007\" data-end=\"5053\">farmaceutick\u00e9, l\u00e9ka\u0159sk\u00e9 a potravin\u00e1\u0159sk\u00e9 obaly<\/strong> z\u016fstaly bezpe\u010dn\u00e9 a neporu\u0161en\u00e9 po celou dobu sv\u00e9ho \u017eivotn\u00edho cyklu. D\u00edky pokro\u010dil\u00fdm \u0159e\u0161en\u00edm, jako je nap\u0159. <strong data-start=\"5141\" data-end=\"5186\">Cell Instruments MLT-01 Mikrotester t\u011bsnosti<\/strong>, mohou spole\u010dnosti dos\u00e1hnout konzistentn\u00ed, citliv\u00e9 a efektivn\u00ed <strong data-start=\"5247\" data-end=\"5278\">testov\u00e1n\u00ed neporu\u0161enosti obalu<\/strong> v souladu s celosv\u011btov\u00fdmi standardy kvality.<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>V\u00fdznam normy ASTM F2338 pro kvalitu obal\u016f Obaly slou\u017e\u00ed jako prvn\u00ed bari\u00e9ra proti kontaminaci. I mikroskopick\u00e9 net\u011bsnosti v t\u011bsn\u011bn\u00ed nebo materi\u00e1lech mohou umo\u017enit vniknut\u00ed kysl\u00edku, vlhkosti nebo mikroorganism\u016f. U farmaceutick\u00fdch v\u00fdrobk\u016f m\u016f\u017ee jedin\u00e1 nezji\u0161t\u011bn\u00e1 net\u011bsnost ohrozit bezpe\u010dnost pacienta. Norma ASTM F2338 \u0159e\u0161\u00ed tento probl\u00e9m t\u00edm, \u017ee nab\u00edz\u00ed validovanou, nedestruktivn\u00ed a opakovatelnou zkou\u0161ku, kter\u00e1 [...]<\/p>","protected":false},"featured_media":7869,"parent":0,"template":"","meta":{"_acf_changed":true,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}}},"standard-category":[611],"class_list":["post-9857","standard","type-standard","status-publish","has-post-thumbnail","hentry","standard-category-astm"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/standard\/9857","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/standard"}],"about":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/types\/standard"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/media\/7869"}],"wp:attachment":[{"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/media?parent=9857"}],"wp:term":[{"taxonomy":"standard-category","embeddable":true,"href":"https:\/\/www.packqc.com\/cs\/wp-json\/wp\/v2\/standard-category?post=9857"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}